FLL · Class II · 21 CFR 880.2910

FDA Product Code FLL: Continuous Measurement Thermometer

Under FDA product code FLL, continuous measurement thermometers are cleared for ongoing body temperature monitoring in clinical settings.

Unlike intermittent spot-check thermometers, these devices provide a continuous temperature reading through sustained contact with the patient — typically via a skin patch, rectal probe, or esophageal sensor — enabling real-time detection of fever onset and temperature trends in critically ill patients.

FLL devices are Class II medical devices, regulated under 21 CFR 880.2910 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Microlife Intellectual Property GmbH, R & D Batteries, Inc. and Taidoc Technology Corporation.

798
Total
798
Cleared
139d
Avg days
1976
Since
798 devices
169–192 of 798
Cleared Jul 18, 2018
Braun BFH175 Infrared Forehead Thermometer
K181015
Kaz USA, Inc., A Helen of Troy Company
General Hospital · 92d
Cleared Jul 12, 2018
Infrared Thermometer
K172874
Shenzhen Jiacom Technology CO ., Ltd.
General Hospital · 294d
Cleared Jul 11, 2018
Infrared Thermometer
K180314
Xuzhou Yongkang Electronic Science Technology Co., Ltd.
General Hospital · 156d
Cleared Jun 07, 2018
Digital Thermometer
K172121
Fudakang Industrial Co., Ltd.
General Hospital · 329d
Cleared May 25, 2018
Infrared Thermometer
K172889
Shenzhen Pacom Medical Instruments Co., Ltd.
General Hospital · 246d
Cleared May 17, 2018
Infrared Thermometer
K172894
Shenzhen Jiacom Technology CO ., Ltd.
General Hospital · 237d
Cleared May 11, 2018
Infrared Body Thermometer
K180385
Hetaida Technology Co., Ltd.
General Hospital · 88d
Cleared Apr 19, 2018
AViTA Radar Thermo NT16 Series IR Thermometer
K172427
Avita Corporation
General Hospital · 252d
Cleared Mar 21, 2018
ATS Thermal Imaging Probe, ATS Patient Interface Unit
K180148
Securus Medical Group, Inc.
General Hospital · 61d
Cleared Mar 14, 2018
Infrared Thermometer
K172795
Shenzhen Jumper Medical Equipment Co., Ltd.
General Hospital · 180d
Cleared Mar 02, 2018
Infrared Thermometer
K171214
Shenzhen Brav Electronic Technologies Co., Ltd.
General Hospital · 311d
Cleared Feb 13, 2018
Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J
K172870
Hangzhou Hua'An Medical&Health Instruments Co.,Ltd
General Hospital · 146d
Cleared Feb 09, 2018
AT-6XX Series Infrared Thermometer
K171455
Xiamen Acurio Instruments Co., Ltd.
General Hospital · 268d
Cleared Jan 17, 2018
Medline Disposable Electronic Thermometer Probe Cover
K173113
Medline Industries, Inc.
General Hospital · 110d
Cleared Jan 17, 2018
Kinsa QuickCare Thermometer
K173730
Kinsa, Inc.
General Hospital · 42d
Cleared Jul 20, 2017
Microlife Digital Infrared Ear Thermometer
K170219
Microlife Intellectual Property GmbH
General Hospital · 176d
Cleared May 20, 2016
Temperature Probe, Affinity Temperature Probe
K160091
Medtronic, Inc.
General Hospital · 126d
Cleared May 06, 2016
TD-1035 Thermometer
K152680
Taidoc Technology Corporation
General Hospital · 231d
Cleared Mar 29, 2013
NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER
K122221
Taidoc Technology Corporation
General Hospital · 247d
Cleared Feb 05, 2013
DIGITAL THERMOMTER
K122520
Taidoc Technology Corporation
General Hospital · 172d
Cleared Jun 06, 2012
FORA COMFORTSCAN EAR THERMOMETER
K120712
Taidoc Technology Corporation
General Hospital · 90d
Cleared Jan 27, 2012
MICROLIFE DUAL MODE THERMOMETER,MODEL IFR1MJ1
K113141
Microlife Intellectual Property GmbH
General Hospital · 95d
Cleared Jan 06, 2012
U-RIGHT TD-1240 THERMOMETER
K113159
Taidoc Technology Corporation
General Hospital · 72d
Cleared Aug 15, 2011
ION HEALTH USB INSTA-SCAN THERMOMETER
K111974
Taidoc Technology Corporation
General Hospital · 34d